Study of CM310 in Adolescent Subjects With Atopic Dermatis

Keymed Biosciences

Status and phase

Not yet enrolling

Phase 3

Conditions

Atopic Dermatitis

Treatments

Biological: CM310

Study type

Interventional

Funder types

Industry

Identifiers

NCT06495229

CM310-101215

Details and patient eligibility

About

This is a multi-center, single arm, open label phase 3 study to evaluate the safety and efficacy of CM310 in children patients with moderate-to-severe atopic dermatitis.

Enrollment

180 estimated patients

Sex

All

Ages

12 to 18 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Have the ability to understand the study and voluntarily sign a written informed consent form (ICF).
Subjects who must complete the evaluation of Week 18 of the main study.
With Atopic Dermatitis.

Exclusion criteria

Any major surgery planned during the research period.
Subjects with potential fertility do not agree to adopt efficient contraceptive measures throughout the entire study period; Pregnant or breastfeeding women, or women planning to conceive or breastfeed during the study period.
With any circumstance that the subject is not suitable to participate in this study.